Diphtheria-Tetanus-Pertussis Vaccine Shortage -- United States

In the past 6 months, major changes have occurred in the
pattern
of manufacture and distribution of diphtheria-tetanus-pertussis*
(DTP)
vaccine in the United States. Now, two of the three U.S.
commercial
manufacturers (Wyeth and Connaught, Inc.) have stopped distribution
of
their products. Thus, only one manufacturer (Lederle) now markets
DTP
vaccine in the United States. Lederle has been increasing its
production and expanding its facilities to meet current needs.
Careful monitoring of supplies and production schedules previously
indicated that national supplies would be adequate. However, some
recent lots of Lederle DTP vaccine have failed to meet the
manufacturer's requirements for release. Production and testing of
this three-component vaccine is complex and requires several
months.
No new vaccine lots may be available until sometime in February
1985.
Comparison of available stocks and the quantity of DTP vaccine now
being distributed with the usual national utilization of DTP
vaccine
indicates that, if current use patterns continue, beginning in
January
1985, supplies of DTP vaccine will be very limited, and some areas
may
be without DTP vaccine. This situation may continue through most
of
1985.

To minimize the health impact of this shortage, two major
options
exist--to reduce the amount of vaccine given in a particular dose
and
to postpone one or more doses. Because it is impossible to predict
the degree of protection conferred by partial doses, this option is
not recommended (1). Consequently, consideration has been given to
the possibility of postponing one or more doses of the current
immunization schedule, which calls for the administration of DTP
vaccine at 2, 4, 6, and 18 months of age, with a fifth dose at 4-6
years of age.

With pertussis, there is a significant risk of infection in
infancy and early childhood, with 2,463 cases reported in 1983 (51%
of
them among infants under 1 year old). Additionally, infants are
more
likely to suffer complications or death from pertussis than are
older
children. Consequently, it is critical to continue providing
protection against pertussis to infants. The first three doses of
DTP
vaccine provide protection against pertussis in 70%-90% of
recipients
and immunity to diphtheria and tetanus in over 90% of recipients
(2-4). The doses given at 18 months and at 4-6 years of age
enhance
protection through the preschool and early school years,
respectively.

Taking all these factors into account, interim postponement of
the
doses of DTP vaccine given at 18 months and at 4-6 years of age
could
achieve substantial savings in the rate of DTP vaccine use, while
still protecting those at greatest risk of these diseases. To have
enough vaccine to provide initial protection to all young infants
until larger quantities of DTP vaccine are again available, it will
be
necessary to begin this approach immediately.

After consultation with members of the Immunization Practices
Advisory Committee and the Committee on Infectious Diseases of the
American Academy of Pediatrics, the following interim
recommendations
are made:

Effective immediately, all health-care providers should
postpone administration of the DTP vaccine doses usually
given at 18 months and 4-6 years of age (fourth and fifth
doses) until greater supplies are available.

When adequate DTP vaccine becomes available, steps should
be
taken to recall all children under 7 years of age who miss
these doses for remedial immunization.
If these recommendations are followed by all providers of DTP

vaccine throughout this temporary vaccine shortage, immunity in
infants will be maintained at the best possible levels. Public
health-care providers and professional organizations throughout the
United States have been notified and are being urged to follow
these
recommendations.
Reported by U.S. Public Health Service Interagency Group to Monitor
Vaccine Development, Production, and Usage.

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